A Study to Learn How Safe and Tolerable Odronextamab and Cemiplimab Are in Adult Patients With B-cell Malignancies
Part of paid clinical trials in Baltimore, Maryland.
- Sponsor
- Regeneron Pharmaceuticals
- Study ID
- NCT02651662
- Phase
- PHASE1
- Status
- Completed
Conditions
- Relapsed/Refractory Aggressive B-Cell Lymphoma
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- cemiplimab — DRUGAdministration via intravenous (IV) infusion. The dose(s) received will be according to dose level (DL) cohort assignment, as described in the protocol.
- odronextamab — DRUGAdministration IV infusion. The dose(s) received will be according to DL cohort assignment, as described in the protocol.
Study Details
This study is researching a combination of 2 experimental drugs, referred to as "study drugs", called odronextamab (also known as REGN1979) and cemiplimab (also known as REGN2810). The study is focused on patients who have relapse/refractory aggressive B-cell lymphoma. The aim of the study is to see how safe and tolerable the study drugs are, and to define the recommended dose regimen for the combination with odronextamab. This study is also looking at several other research questions, including: * What side effects may happen from taking the study drugs * How effective the study drugs are against the disease * How much study drug is in the blood at different times * Whether the body makes substances or protein called antibodies against the study drugs (that could make the drugs less effective or could lead to side effects)
Key Dates
- Start date
- Jan 11, 2016
- Status verified
- May 2026
- Primary completion
- Apr 29, 2026
- Completion
- Apr 29, 2026
Study Design
- Enrollment
- 105 participants (actual)
- Allocation
- NON_RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: Dose escalation phaseSafety assessment of odronextamab in combination with cemiplimab and selection of recommended phase 2 dose (RP2D) regimen(s) for the combination of odronextamab and cemiplimab.
- Experimental: Dose expansion phaseRP2D administration of the combination treatment.
Primary Outcome Measure
Incidence of dose limiting toxicities (DLTs) of cemiplimab in combination with odronextamab [ Time Frame: Up to 28 days ]
Locations (5)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Johns Hopkins University | Baltimore | Maryland | 21205 | - |
| Dana Farber/Harvard Cancer Center - PO box 849168 | Boston | Massachusetts | 02215 | - |
| Harvard Medical School - Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | - |
| Cancer & Hematology Centers of Western Michigan | Grand Rapids | Michigan | 49546 | - |
| University Hospitals Cleveland Medical Center | Cleveland | Ohio | 44106 | - |